ClinicalTrials.gg
Not yet recruitingNCT07904468Updated Oct 29, 2026

Daily Cognitive Failures and Medication Adherence in Fibromyalgia

An observational study in Fibromyalgia, sponsored by Mardin Artuklu University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Mardin Artuklu University · Observational

Updated Oct 29, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
70
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study aims to investigate the relationship between everyday cognitive failures and medication adherence in adults with fibromyalgia.

Fibromyalgia is a chronic condition associated with widespread pain, fatigue, and cognitive difficulties such as forgetfulness and problems with attention. These difficulties may affect patients' ability to take prescribed medications regularly, but their relationship with medication adherence remains unclear.

This single-center, observational, cross-sectional study will include 70 adults aged 18-65 years diagnosed with fibromyalgia who regularly take at least one medication for the condition.

Everyday cognitive failures will be assessed using the Cognitive Failures Questionnaire (CFQ), and medication adherence will be assessed using the five-item Medication Adherence Report Scale (MARS-5). Anxiety and depressive symptoms will be evaluated using the Hospital Anxiety and Depression Scale (HADS). Information on pain severity, medications, and daily medication-taking frequency will also be collected.

The study will examine whether greater cognitive failures are associated with lower medication adherence and whether this relationship remains after accounting for anxiety, depressive symptoms, number of regularly used medications, and daily medication-taking frequency.

All assessments will be completed during a single visit lasting approximately 12-15 minutes. No experimental treatments, additional laboratory tests, or invasive procedures will be performed.

Read the detailed description

Cognitive difficulties are frequently reported by individuals with fibromyalgia and may involve attention, memory, and everyday cognitive functioning. Although cognitive impairment and medication adherence have been investigated separately in fibromyalgia, the relationship between everyday cognitive failures and adherence to prescribed medication remains insufficiently understood.

The primary objective of this study is to evaluate the association between everyday cognitive failures, measured by the Cognitive Failures Questionnaire (CFQ), and medication adherence, measured by the five-item Medication Adherence Report Scale (MARS-5).

The MARS-5 total score will serve as the primary outcome variable, while the CFQ total score will be the main explanatory variable. Higher MARS-5 scores indicate better medication adherence, whereas higher CFQ scores indicate more frequent everyday cognitive failures. For participants using multiple medications for fibromyalgia, adherence will be assessed for the medication used regularly for the longest duration.

The relationship between CFQ and MARS-5 total scores will be examined using Pearson or Spearman correlation analysis, depending on the distribution of the data.

A multivariable linear regression model will additionally be used to assess whether cognitive failures are independently associated with medication adherence after adjustment for anxiety symptoms, depressive symptoms, the number of regularly used medications, and daily medication-taking frequency.

Exploratory analyses will investigate the associations of age, sex, educational level, duration of fibromyalgia, and pain severity with CFQ and MARS-5 scores.

The study will be conducted at the Physical Medicine and Rehabilitation Outpatient Clinic of Mardin Training and Research Hospital, Türkiye. Participants will complete all assessments during a single visit without any additional medical intervention.

As this is a cross-sectional study, the findings will be interpreted as associations and will not establish causal relationships.

02

Conditions studied

  • Fibromyalgia

Keywords

  • Fibromyalgia
  • Cognitive Failures Questionnaire (CFQ)
  • Medication Adherence Report Scale (MARS-5)
  • Hospital Anxiety and Depression Scale (HADS)
  • Medication Adherence
03

In context

Fibromyalgia

1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.

This study's planned enrollment of 70 is below the median of 100 across 279 observational studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Mardin Artuklu University is the lead sponsor of 34 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will consist of 70 adults aged 18-65 years diagnosed with fibromyalgia according to the 2016 ACR criteria and regularly taking at least one medication for fibromyalgia. Participants will be recruited from the Physical Medicine and Rehabilitation Outpatient Clinic of Mardin Training and Research Hospital, Türkiye. Eligible patients who provide written informed consent will undergo a single-visit assessment of everyday cognitive failures, medication adherence, anxiety and depressive symptoms, pain severity, and medication use.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18-65 years.
  • Diagnosis of fibromyalgia according to the 2016 American College of Rheumatology (ACR) criteria.
  • Regular use of at least one medication for fibromyalgia.
  • Willingness to participate in the study and provision of written .

Exclusion criteria

Exclusion Criteria:

  • Cognitive impairment severe enough to prevent reliable completion of the assessment questionnaires.
  • Active psychotic disorder or severe psychiatric illness that significantly interferes with participation in the assessment.
  • Pregnancy, postpartum period, or breastfeeding.
  • Communication difficulties that prevent understanding or answering the study questionnaires.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • Fibromyalgia Group

    Adults aged 18-65 years diagnosed with fibromyalgia according to the 2016 American College of Rheumatology (ACR) criteria and regularly taking at least one medication for fibromyalgia. Participants will undergo a single-visit assessment using the Cognitive Failures Questionnaire (CFQ), Medication Adherence Report Scale (MARS-5), and Hospital Anxiety and Depression Scale (HADS). Demographic characteristics, pain severity, and medication use will also be recorded. No experimental interventions or additional medical procedures will be performed.

06

What researchers measure

Primary outcomes

  1. Medication Adherence Assessed by MARS-5 in Relation to Pain Severity

    Medication adherence will be measured using the five-item Medication Adherence Report Scale (MARS-5). Total scores range from 5 to 25, with higher scores indicating better medication adherence. The association between MARS-5 total scores and pain severity, assessed using the Numeric Rating Scale (NRS; 0-10), will be examined as an exploratory analysis. MARS-5 will be the outcome variable, and pain severity will be the explanatory variable.

    Time frame: Baseline

Secondary outcomes

  1. Everyday Cognitive Failures Assessed by the Cognitive Failures Questionnaire (CFQ)

    Everyday cognitive failures will be assessed using the 25-item Cognitive Failures Questionnaire (CFQ). Each item is scored from 0 to 3, yielding a total score ranging from 0 to 75. Higher scores indicate more frequent everyday cognitive failures, whereas lower scores indicate fewer cognitive failures.

    Time frame: Baseline

  2. Anxiety Symptoms Assessed by the Hospital Anxiety and Depression Scale (HADS-A)

    Anxiety symptoms will be assessed using the seven-item anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). Each item is scored from 0 to 3, yielding a total score ranging from 0 to 21. Higher scores indicate more severe anxiety symptoms, whereas lower scores indicate fewer anxiety symptoms.

    Time frame: Baseline

Other outcomes

  1. Pain Severity Assessed by the Numeric Rating Scale (NRS)

    Average fibromyalgia pain severity during the preceding week will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain severity, whereas lower scores indicate less pain.

    Time frame: Baseline

07

Study locations

1 site
08

References and documents

Publications

  • Prikhodkina M, Melnikov S. Factors that influence medication adherence in women with fibromyalgia: A path analysis. J Clin Nurs. 2024 Oct;33(10):3943-3953. doi: 10.1111/jocn.17044. Epub 2024 Jan 29. PubMed 38284436 ↗
  • Ben-Ami Shor D, Weitzman D, Dahan S, Gendelman O, Bar-On Y, Amital D, Shalev V, Chodick G, Amital H. Adherence and Persistence with Drug Therapy among Fibromyalgia Patients: Data from a Large Health Maintenance Organization. J Rheumatol. 2017 Oct;44(10):1499-1506. doi: 10.3899/jrheum.170098. Epub 2017 Aug 1. PubMed 28765248 ↗
  • Wu YL, Huang CJ, Fang SC, Ko LH, Tsai PS. Cognitive Impairment in Fibromyalgia: A Meta-Analysis of Case-Control Studies. Psychosom Med. 2018 Jun;80(5):432-438. doi: 10.1097/PSY.0000000000000575. PubMed 29528888 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2026; primary completion for Nov 2027, 11 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2026
First posted
Oct 29, 2026
StartEst.
Dec 15, 2026
Primary completionEst.
Nov 15, 2027
CompletionEst.
Dec 15, 2027
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07904468
Lead sponsor
Mardin Artuklu University
Collaborators
Mardin Training and Research Hospital
Responsible party
Taha Yasin YILDIRIM (Physical Medicine and Rehabilitation Specialist, Mardin Artuklu University) — Principal investigator
First posted
Oct 29, 2026
Start date
Dec 15, 2026 (estimated)
Primary completion
Nov 15, 2027 (estimated)
Completion
Dec 15, 2027 (estimated)
Last update
Oct 29, 2026

Study contacts

Taha Y Yıldırım, M.D.
Contact
tyasinyildirim.ftr@gmail.com
+90 534 220 77 17

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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